Indonesia MoH registration

Indonesia Medical Device Registration

Healthcare is a priority in Indonesia’s national development agenda. Hence, it presents excellent opportunities for foreign exporters of medical equipment and supplies.Qualtech  is your ideal partner to for your foray into the Indonesia medical device market for an easy and smooth registration process.

Qualtech in Indonesia

IPAK Certificate

We are Indonesia Government approved entity to process regulatory and distribution work of medical device. We successfully assisted foreign manufacturers to access local market.

Expert in Non-active Device

We offer clients an efficient registration way for high risk products to open local market in a short time. We have obtained 100 cases approval.

 

 

QT Services
 
 
 
 

Medical Device Registration

Our in – house experts are able to provide you with excellent professional service in preparing customized ASEAN Common Submission Dossier Template (CSDT) and liaise with MoH officers to get your devices registered in the Indonesia.

 
 

Authorized Representation

As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical devices in Indonesia. This is in compliance with the law for a local establishment to be a license holder.

 
 

Importation

The local distributor you are looking is sometimes not a qualified importer, or is not familiar with the importation process of medical device. Qualtech has extensive experience in importation in many regions of Asia, assisting several customers to handle customs clearance of various medical equipment imports. We can assist your products to be delivered to customers smoothly!

 
 

E-katalog Application

We also provide professional guidance and service for local manufacturers, importers, distributors and authorised representatives to apply for an E-katalog License with MoH. Having a team of local consultants who are well-versed in the requirements of local regulations, your journey will be smooth with us.

 

Registration with MoH

The registration of medical device in Indonesia is highly regulated by Medical Device and Household Product Assessment Directorate, which is under the Ministry of Health(MoH). Marketing license will be issued after MoH review applicant’s documentation. MoH only give applicant one chance to comply with the requirement. Import products should be registered and marketed by local distributor who is equipped with an IPAK license (medical device distributor license). It’s noticeable that one particular brand can only be registered by one distributor.

Classification
 
 

 

Class A

Low risk device

Marketing License

Online submission

Class B

Low-Moderate Risk

Marketing License

Online submission

Class C

High-Moderate Risk

Marketing License

Online submission

Class D

High Risk

Marketing License

Online submission

 

 

TECHNICAL REQUIREMENTS

Qualtech CLASS A CLASS B CLASS C CLASS D
Executive Summary Yes Yes Yes
Essential Principles and Methods Yes Yes Yes
Device Description Yes Yes Yes Yes
Summary of Design V&V Yes Yes Yes Yes
Labeling and IFU Yes Yes Yes Yes
Risk Assessment Yes Yes Yes
Physical Manufacturer Information Yes Yes Yes Yes
Clinical Evidence Yes Yes Yes
PMS Plan and Report Yes Yes Yes

Note: Kindly see the Pedoman Penilaian Alat Kesehatan Sesuai Dengan Permenkes Nomor 62/2017 issued on 2019 for more details.

Workflow
 
 

MoH Target Reviewing Turnaround Time

After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the MoH and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.

  CLASS A CLASS B CLASS C CLASS D
1st Evaluation 15 30 30 45
Compliance 10 10 10 15
2nd Evaluation 10 10 10 10
  • Note:
  1. 1. It’s accounted as Working days.
  2. 2. There is only one opportunity to comply with evaluator’s additional input requests.
Validity
 
 
  • Types of Certificates: Marketing License

  • Marketing License: Depends on validity of LOA, max is 5 years

 
Tips
 
 
Could I Change Distributor?

Some manufacturers might face the poor selling performance in Indonesia, and would like to exchange the sole distributor. We have received several inquiries from our clients or partners in local.

Unfortunately, it’s a hard task to change new local agent in Indonesia because of law restriction – MoH requests the no objection letter from the current local agent. Usually the local authorization representative is unwilling to offer this letter.

 

To avoid this situation from the sales work in Indonesia, we would suggest put license in 3rd party, such as Qualtech.

 

For more information, please refer to the MoH’ official website or you may contact us for a free consultation.

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Official Website
 
 

 

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